Skip to content

Artificial Intelligence Self Harm Application

Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019663
Acronym
AISHA
Enrollment
312
Registered
2023-08-31
Start date
2024-06-01
Completion date
2025-12-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-harm, Suicide

Keywords

self-harm, suicide, adolescents, young people, artificial intelligence, problem-solving, CBT, Pakistan, LMIC, Digital

Brief summary

This is a mixed-methods study. The quantitative component will comprise of a multicentre rater-blind, randomized controlled trial to evaluate the feasibility and acceptability of AISHA in addition to treatment as usual (TAU) compared to TAU alone in Pakistan. In-depth interviews and focus groups with other stakeholders will take place to consider the wider implementation of AISHA in mental health services in Pakistan.

Detailed description

Mental health resources in LMICs, including Pakistan, do not match the burden of mental illness, resulting in a massive mental health treatment gap. Interventions delivered on mobile platforms (M-Health) have the potential to overcome these barriers. Evidence supports the acceptability and efficacy of interventions delivered on digital platforms for a variety of mental disorders. Mobile-based interventions have been developed to target self-harm, however, there is paucity of research supporting their efficacy in LMIC. To our knowledge there are currently no clinical trials examining the feasibility, acceptability and preliminary efficacy of a culturally adapted CBT informed problem solving intervention delivered on a digital platform for self-harm prevention.We have developed an Artificial Intelligence Self-Harm prevention Application (AISHA) to deliver an evidence-based problem solving intervention (CMAP) for people presenting with self-harm.

Interventions

BEHAVIORALThe Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP

YCMAP is a Youth culturally adapted manual assisted psychological intervention based on CBT principles. The therapy focuses on current problems that contributed to the self-harm episode. Therapists and adolescent clients choose from a list of techniques those which are most relevant to the client's problems. Therapy is therefore adapted to fit with the client's problems and primarily utilises problem solving, CBT, and dialectical therapy strategies to bring about change.

Sponsors

Pakistan Institute of Living and Learning
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* All patients presented to the participating family physicians, community health centres, emergency departments or admitted to a general hospital after an episode of self-harm at participating sites. * Age 16 to 25 years * Participants must be familiar with functioning of handheld mobile devices (mobile phones, tablets). * Able to read Urdu or English language. * Individuals able to provide written informed consent. * Have an android mobile phone/device

Exclusion criteria

* Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability which prevents participation. * Participants needing inpatient psychiatric treatment as determined by their clinical teams

Design outcomes

Primary

MeasureTime frameDescription
Beck Scale for Suicide IdeationChange in scores from baseline to 3-month follow up (end of intervention)This is a self-report measure of current suicidal ideation. Higher scores (≥6) on the scale indicate greater risk. When measured against other instruments of suicidal ideation, the convergent validity of the BSI has been demonstrated, r= 0. We have used the Urdu translated version of this instrument in prior work from Pakistan and found the Cronbach's alpha to be 0.89 (M. O. Husain et al., 2019). Higher scores indicate greater severity of suicidal ideation

Secondary

MeasureTime frameDescription
Beck Depression InventoryChange in scores from baseline to 3-month follow up (end of intervention)This is a 21-item scale of depressive symptoms. Higher scores on the scale indicate greater severity of depression. Mild depression is indicated by scores of 14 -19; Moderate depression scores of 20 - 28 and Severe depression scores of 29-63.
Coping resource inventoryChange in scores from baseline to 3-month follow up (end of intervention)The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. Higher scores indicate better coping skills
The Resilience ScaleChange in scores from baseline to 3-month follow up (end of intervention)The RS is a 25-item self-report scale that aims to assess an individual's level of resilience. This is a 7 point Likert Scale and provides a total score of resilience, ranging from 25 to 175, with higher scores indicative of higher levels of resilience.
Beck Hopelessness ScaleChange in scores from baseline to 3-month follow up (end of intervention)This is a 20-item self-report instrument designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations. Higher scores indicate increasing severity of hopelessness; normal (0-3), mild hopelessness (4-8), moderate hopelessness (9-14), severe hopelessness (\>14).
Euro-Qol Quality of Life ScaleChange in scores from baseline to 3-month follow up (end of intervention)This is an instrument which is used to measure quality of life or health profiles of participants. Higher scores indicate higher health related quality of life
Client Satisfaction QuestionnaireLevel of satisfaction with the services received at end of intervention i.e., 3-month post-randomizationThis is an eight item self-report questionnaire used to assess participant's satisfaction with the services using a 4-point likert scale. Higher scores indicate greater satisfaction.
Client Service Receipt InventoryChange in scores from baseline to 3-month follow up (end of intervention)This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)
The Problem Solving InventoryChange in scores from baseline to 3-month follow up (end of intervention)The PSI is a 35-item instrument that measures the individual's perceptions regarding one's problem-solving style and problem-solving abilities in the everyday life. It consists of three subscales. Higher scores indicate higher level of problem solving abilities

Countries

Pakistan

Contacts

Primary ContactNasim Chaudhry
nasim.chaudhry@pill.org.pk02135871845
Backup ContactSehrish Tofique
sehrish.tofique@pill.org.pk03242939563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026